‘Indian regulatory system very hierarchical’

Describing the problems that leading Indian pharmaceutical companies are facing when it comes to global and domestic regulations, UK based healthcare consulting company, Woodley BioReg talks to BioSpectrum exclusively based on its extensive experience in the global regulatory market

Though the number of manufacturers in India is huge, documental evidence suggests that many do not really understand the nuances behind the cGMP

Singapore: In an effort to smoothen out the understanding of global regulations amongst Indian companies, Ms Carolyn Beeden, General Manager and Mr Ash Ramzan, Principal Consultant, Woodley BioReg have been working very closely with many firms.

In the light of global regulatory patterns leading towards harmonization, the FDA has initiating many programs like the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Pharmaceutical Inspection Cooperation Scheme and the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee.

However, the understanding of all these regulations and the changes in it, often gets misinterpreted or completely ignored by firms across the world. This is where UK based healthcare consulting firm, Woodley BioReg gets into the picture, Mr Ramzan explained.

"We deal with generics and have been helping companies file documents that are aligned with the regulations," he added.

"Some of the main problems that we have encountered amongst Indian firms when it comes to regulations is recalls, shutdowns and import alerts being issues - which are most prevalent problems. We look at analyzing the problem, fixing it and then even preventing it in the future," explained Mr Beeden.